Regulatory Counsel (Ombudsman)

The Ombudsman acts as an independent mediator in disputes related to the regulated industry to resolve issues in a manner that is timely, fair, and impartial. Providing supervision during the ongoing assessment and audits of regulatory matters and quality solutions, such as identifying corrective action plan and/or establishing the appropriate standard operating procedures. Overseeing information-gathering, data collection, and fact-finding throughout multiple organizations with affected persons and groups both internal and external. Overseeing the complaint process related to the scientific, regulatory, and administrative decisions which impacts the Agency’s pending regulatory matters. Collaborating with other key personnel during the regulatory decision-making process with a goal towards improving procedures and increasing public confidence in the safety, effectiveness, and quality of biological related products. Providing supervision during the ongoing assessment and audits of regul